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Oxlumo (lumasiran) and Rivfloza (nedosiran) — Coverage Criteria (Ohio)
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Defines medical benefit drug coverage criteria for Oxlumo and Rivfloza for treatment of primary hyperoxaluria type 1 (PH1); applies to requests evaluated under Ohio jurisdiction per the policy.
No material clinical or coverage changes in this revision.
Coverage Criteria for Oxlumo and Rivfloza
Initial Therapy — Oxlumo (lumasiran)
Oxlumo (lumasiran) is covered when ALL of the following are met for initial therapy:
Documentation of baseline and on-treatment laboratory values should be submitted as medical records to support response assessment.
Initial and Continuation Therapy — Rivfloza (nedosiran)
Rivfloza (nedosiran) is covered when ALL of the following are met for initial therapy:
Age and kidney function thresholds reflect FDA-labeled indication and policy requirements.
Provide laboratory documentation comparing on-treatment values to pre-treatment baseline to support continued benefit.
Use of Oxlumo (lumasiran) and Rivfloza (nedosiran) together is not permitted. The policy explicitly states that a patient must not be receiving Oxlumo in combination with Rivfloza (and conversely must not be receiving Rivfloza in combination with Oxlumo) as a condition of coverage.
Therapy with either agent is covered only when all specified coverage requirements are met. Requests that do not include a confirmed diagnosis of PH1, required metabolic or genetic testing (as applicable), documentation of specialist prescribing or consultation, adherence to FDA-approved dosing, demonstration of treatment response or required clinical documentation, and applicable kidney function thresholds will not meet medical necessity. Additionally, prior authorization and the documented conditions for initiation or continuation (including limits on initial and reauthorization periods) must be satisfied for coverage to be approved.
Diagnosis and Billing Codes
| E72.530 | Primary hyperoxaluria, type 1 |
| E72.538 | Other specified primary hyperoxaluria |
| E72.539 | Primary hyperoxaluria, unspecified |
| E72.541 | Enteric hyperoxaluria |
| E72.548 | Other secondary hyperoxaluria |
| E72.549 | Secondary hyperoxaluria, unspecified |
Provider Actions, Prior Authorization, and Documentation
Prior authorization required; authorizations ≤ 12 months
Prior authorization is required for Oxlumo (lumasiran) and Rivfloza (nedosiran). Initial authorizations and reauthorizations are each limited to no more than 12 months; requests for services will be evaluated under Ohio Administrative Code when applicable.
Specialist prescribing; combination therapy disallowed; follow FDA dosing
Therapy must be prescribed by, or in consultation with, a specialist with PH1 expertise (e.g., geneticist, nephrologist, urologist). Combination use of Oxlumo and Rivfloza is not permitted. Dosing must follow United States FDA–approved labeling.
- Specialist requirement applies to both initial and continuation requests.
- Explicit exclusion: patient must not be receiving Oxlumo in combination with Rivfloza (and vice versa).
- Dosing per FDA label for the specific product requested.
Required documentation (chart notes, labs, genetic testing, response data)
Submit medical records documenting diagnosis confirmation and, for continuation requests, evidence of positive clinical response compared with pretreatment baseline.
- Chart notes confirming diagnosis of PH1 and specialist consultation.
- Laboratory values such as metabolic testing showing increased urinary oxalate excretion (e.g., >1 mmol/1.73 m2/day or increased urinary oxalate:creatinine ratio) or increased plasma oxalate/glyoxylate concentrations.
- For nedosiran (Rivfloza) initial requests: genetic testing confirming AGXT mutation.
- For continuation: documentation of decreased urinary oxalate concentrations, decreased urinary oxalate:creatinine ratio, or decreased plasma oxalate concentrations.
Denial risk if coverage criteria, dosing, specialist involvement, or documentation are unmet
Requests may be denied if the coverage criteria are not met — including lack of diagnostic confirmation, absence of specialist involvement, failure to follow FDA dosing, or missing required documentation.
- Denial risk if metabolic testing does not demonstrate increased urinary oxalate excretion or increased plasma oxalate/glyoxylate.
- Denial risk if no specialist (or consultation) with PH1 expertise is documented.
- Denial risk if genetic confirmation (AGXT mutation) is required for nedosiran and not provided.
- Denial risk if combination therapy with the other agent is present.
Background
Primary hyperoxaluria type 1 (PH1) is an autosomal recessive metabolic disorder caused by mutations in the AGXT gene that lead to hepatic overproduction of oxalate and progressive kidney damage. The resulting excess oxalate increases urinary and plasma oxalate concentrations, placing patients at risk for nephrolithiasis, nephrocalcinosis, and end-stage renal disease. Lumasiran (Oxlumo) and nedosiran (Rivfloza) are small interfering RNA therapies that target hepatic enzymes in the oxalate production pathway to reduce urinary and/or plasma oxalate levels and are used in PH1 under the coverage conditions described in this policy.
Definitions
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